MDCG 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED
A guidance document has been released on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED. To offer some background to this guidance document, Article 77(5) of the MDR mandates that sponsors submit a clinical investigation report to the Member States where the clinical investigation was conducted within one ...
EU Commission Release Q&A regarding Gradual Rollout of EUDAMED
The European Commission has recently released a comprehensive Q&A document designed to assist manufacturers and other stakeholders in understanding the new amendment concerning the phased implementation of EUDAMED. This amendment, introduced through Regulation (EU) 2024/1860, was published in mid-June and addresses three key areas within the framework of the Medical Device Regulation (MDR) and In ...
EU Parliament Adopts the Proposal Put Forward by the EU Commission Regarding the Gradual Roll-out of EUDAMED
The EU Parliament has also adopted the proposal regarding the gradual roll-out of EUDAMED which will facilitate the launch of parts of the Database. This means that the mandatory use of several parts of EUDAMED will start from as early as Q4 of 2025/Q1 of 2026. This gradual roll-out of EUDAMED will help increase transparency ...
EU Commission Proposes Gradual EUDAMED Rollout
The EU commission is proposing making some of the EUDAMED modules mandatory at an earlier stage, by Quarter 4 of 2025. Under the current legislation, EUDAMED will become mandatory when all 6 modules are functional, which due to some delays in the development of the module for clinical investigations/performance studies, would be late 2029. Under ...
